CrawlJobs Logo

Associate Director, Investigations

United States, Alpharetta 154000.00 - 180000.00 USD / Year · Job Posted December 23, 2025
Apply Position
Job Link Share

Job Description

The Associate Director, Investigations provides senior leadership and advanced support for all elements of the Ethics & Compliance Program including business team guidance, communication of compliance written standards, key control testing for significant risks, and other related activities as necessary. This role specifically focuses on managing the Third-Party Risk and Global Investigations processes to ensure that ensure compliance with applicable laws, regulations, and Avanos policies.

Job Responsibility

  • Oversight: Supports the implementation of the Global Compliance Program under the direction of the Chief Ethics & Compliance Officer
  • Risk Assessment Activities: Supports the annual Risk Assessment and reviews activity-specific plans by the business teams
  • Third Party Management: Leads the Third Party Seller and Non-seller Third Party (NSTP) compliance management and initiatives
  • Investigations: Leads the investigations into Ethics & Compliance related issues, allegations, or identified areas of risk
  • Helpline: Owns the helpline vendor relationship and managements the system, data flows and communications with internal and external stakeholders
  • Corrective Actions: Implements and tracks appropriate and consistent corrective actions for identified compliance issues and assessment activities
  • Written Standards: Provides support on the drafting, implementation and communication of Compliance-related policies and procedures
  • Program Management: Implements actions as specified in the annual work plan and KPIs
  • Training and Communications: Supports the implementation of the annual training and education plans
  • Monitoring and Auditing: Supports the Audit, Monitoring and Investigations teams in activities as required
  • Advice and Guidance: Provides day-to-day advice and guidance to relevant business teams on Compliance matters

Requirements

  • Bachelor’s degree or its non-U.S. equivalent – required
  • Advanced degree, including MBA, JD, or equivalent - required
  • 7+ years of experience at a medical device, pharmaceutical, or other healthcare organization implementing a compliance program or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions)
  • Expertise in Marketing or other fields will be considered upon demonstration of skill sets needed to perform the job duties
  • Experience in Healthcare industry – Device, Pharma, or Biotech is preferable
  • English language fluency required
  • Valued Advisor to business leaders with experience finding solutions to complex ethical issues
  • Excellent research, writing, and communication skills, and excellent ability to analyze complex matters and present them simply and clearly
  • Excellent organizational and time management skills with the ability to prioritize and manage a heavy and multi-directional workload
  • Demonstrates Integrity and commitment to the highest ethical standards and personal values
  • Ability to work independently and as part of a team (cooperative, encourages collaboration, builds consensus, easily gains the trust and support of superiors and peers, and finds common ground and solves problems)
  • Self-motivated and result driven
  • Instinct to detect risk areas and red flags
  • Solution-minded
  • desire to solve problems
  • Ability to work in a matrixed organization, across cultures and functions with all levels of the organization
  • Ability to prioritize according to risk and make quick decisions with appropriate independence
  • Ability to deal with ambiguity and change
  • Ability to follow through and complete tasks on time
  • Ability to think strategically and also excel at tactical responsibilities
  • Natural leadership ability with enthusiasm, confidence, and self-esteem, balanced with a caring for people that invites others to seek his or her advice and judgment and encourages teamwork and cooperation
  • Strong business acumen with good judgment and can provide business partners with timely and appropriately risk-balanced advice and guidance
  • Stamina and self-assurance to maintain effective working relationships in a demanding and diverse environment
  • Contributes to an environment of respect and collaboration with peers and other stakeholders
  • Exemplifies the values recognized as critical to Avanos: Customer-Centric, Global Mindset, Accountability, Collaborative, Candor, and Speed

Nice to have

  • Specific training in healthcare compliance, privacy and other related topics – preferred
  • Fluency in other languages preferred

What we offer

  • benefits on day 1
  • free onsite gym
  • onsite cafeteria
  • HQ region voted 'best place to live' by USA Today
  • uncapped sales commissions
  • generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
  • attractive incentive compensation program

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Associate Director, Investigations

8 matching positions

Associate Director / Director, Clinical Quality Assurance

Location
Location
United States , Cambridge
Salary
Salary:
185000.00 - 260000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
  • Experience in a clinical stage biotech company preferred
  • 10+ years of relevant experience in clinical/GCP quality
  • Outstanding expertise in GCP R3 and solid understanding of PV regulations
  • Demonstrated ability to successfully partner cross-functionally
  • Excellent interpersonal effectiveness, including exceptional communication skills
  • Advanced computer skills, including experience working in Veeva
  • Consistent excellent judgement and pragmatic, risk-based decision making skills
  • Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities
Job Responsibility
Job Responsibility
  • Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
  • Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
  • Support health authority inspections, including document review, response coordination, and follow-up remediation activities
  • Serve as the Clinical QA Lead for assigned studies and programs
  • Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
  • Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
  • Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
  • Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
  • Support TMF migration activities, as required
  • Lead quality investigations, root cause analysis, and CAPA development
  • Fulltime
Read More
Arrow Right

Clinical Scientist Associate Director – Late Development, Oncology

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...
Location
Location
Portugal , Lisbon
Salary
Salary:
79656.90 - 107771.10 EUR / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 3 years of life sciences/healthcare experience
  • Master's degree and 5 years of life sciences/healthcare experience
  • Bachelor's degree and 7 years of life sciences/healthcare experience
Job Responsibility
Job Responsibility
  • Support set up and execution of late phase clinical trials with a focus on data quality
  • Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
  • Provide input into and implementation of data management plan, CRF design, and data review oversight
  • Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
  • Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
  • Anticipate and actively manage problems across a broad spectrum of cross-functional teams
  • Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
  • Support appropriate training, recruitment, and development requirements for matrix team resources
What we offer
What we offer
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
  • Fulltime
Read More
Arrow Right

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...
Location
Location
Spain
Salary
Salary:
90787.65 - 122830.35 EUR / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 3 years of life sciences/healthcare experience
  • Master’s degree and 5 years of life sciences/healthcare experience
  • Bachelor’s degree and 7 years of life sciences/healthcare experience
Job Responsibility
Job Responsibility
  • Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
  • Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
  • Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
  • Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
  • Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
  • Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
  • Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
  • Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
  • Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
  • Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders
  • Fulltime
Read More
Arrow Right

Associate Director Quality Assurance

Responsible for providing oversight and leadership for Quality on-the-floor and ...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
  • 10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
  • Direct experience with bulk manufacturing of biopharmaceuticals preferred
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
  • Your selection for this role will be subject to fulfilling the medical requirements of this job scope
Job Responsibility
Job Responsibility
  • Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
  • Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
  • Ensure required Quality resources are available to support commercial operations
  • Inspection Readiness and Support
  • Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
  • Support site/network driven QA continuous improvement initiatives/activities
  • Escalate significant quality issues to Quality Management in a timely manner
  • Act as delegate to Quality Assurance Director when required to support business needs
  • Support Drug Substance Alignment Meetings for Functional areas
  • Providing guidance to the team
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Associate Director - Corporate Strategy & Development

Microsoft is on a mission to empower every person and every organization on the ...
Location
Location
United States , Redmond
Salary
Salary:
106400.00 - 203600.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master's Degree in Business Administration or related field AND 3+ years marketing, strategy, business planning, consulting, banking, finance, economics, and/or partner organization experience OR Bachelor's Degree in Business, Finance, Economics, Liberal Arts, Computer Science, or related field AND 4+ years marketing, strategy, business planning, consulting, banking, finance, economics, and/or partner organization experience OR equivalent experience.
Job Responsibility
Job Responsibility
  • Leads key strategy projects and orchestrate workstreams across the Corporate Strategy team
  • owns overall efforts (i.e., full accountability of projects), including project plans, recommendations, impact, and syndication across groups
  • Coaches and mentors team members. Provides professional development guidance and opportunities to project team members
  • Develop and deliver divisional level analysis, options, execution plans, and recommendations based on analytical rigor, logic, and subject matter expertise
  • Proactively spot strategic opportunities missed by others and plot insightful approaches to address them
  • Investigates and provides an analysis of competitors, partners, business models, market sizing, and industry trends. Investigates and provides analysis of the merger and acquisition (M&A), venture funding, and public market environment and trends. Conducts market landscape analyses and reviews of companies of potential interest. Provides guidance to business partners to inform decision-making
  • Develops an understanding of Microsoft’s product portfolio, strategic priorities, competitive position, gaps, and potential opportunities. Investigates and provides an analysis of the merger and acquisition (M&A), venture funding and public market environment and trends. Supports and reviews product roadmap, go-to-market, integration plans, and related Issues
  • Defines initial framing of strategic questions and analyses for project team to conduct
  • Leads project team and/or independently conducts market-based research, including identifying and gathering information (e.g., financial statements, reports, analyses, stakeholder feedback, expert calls)
  • interprets information with guidance from senior colleagues as needed, including researching existing business and identifying new spaces for Microsoft
  • Fulltime
Read More
Arrow Right

External Supply - Manufacturing Support - Associate Director

The External Supply Associate Director of Manufacturing support will report dire...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 8+ years of experience in pharmaceutical Manufacturing positions
  • 4+ years management experience
  • Bachelor's Degree or combination of education and/or years of experience
  • Master's degree and 6 years of Manufacturing / Operations experience OR Bachelor's degree and 8 years of Manufacturing / Operations experience OR Leadership Experience of directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Job Responsibility
Job Responsibility
  • Serving on the ACDM leadership team
  • Providing leadership to the organization that provides manufacturing support to identify and resolve manufacturing, process and system issues associated with external manufacturing operations
  • Developing and implementing a departmental strategy which aligns with the broader organizational strategy
  • Ensuring external manufacturing associated metrics and measures meet requirements
  • Delivering on headcount, productivity and budget targets
  • Effectively collaborate with key customers and support groups in External Supply and across the Amgen Network to ensure best practices are applied to assigned CMOs
  • Build, develop and retain a diverse and high performing team
  • Responsible for product lifecycle management and associated electronic batch records as well as for the support of new product introductions and capital projects being implemented into manufacturing within CMOs
  • Responsible for the Process Owner organization which provides process support for all external manufacturing areas, including support for process improvement and aseptic compliance and supporting manufacturing in delivering supply to patients
  • Driving improvements to the investigation process, right first-time investigation reports and records
  • Fulltime
Read More
Arrow Right

Associate Director, Compliance Systems & Analytics

The Associate Director, Compliance Systems and Analytics, is primarily responsib...
Location
Location
United States , San Mateo
Salary
Salary:
167000.00 - 195000.00 USD / Year
dompe.com Logo
Dompé
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in a related field (e.g., Data Science, Computer Science, Life Sciences)
  • 8+ years of experience in U.S. healthcare compliance, with expertise in data operations, governance, and strategy
  • Extensive experience with laws, regulations, and industry guidance that affect the biotech, pharmaceutical, and rare disease space, including but not limited to OIG, PhRMA Code, healthcare standard operating procedures, ABAC laws, and transparency reporting
  • Demonstrated understanding of U.S. healthcare compliance data assets and data ecosystems
  • Strong analytical and technical skills
  • proficiency in common analytics and CRM tools such as Excel, BI tools (Looker, Tableau)
  • Hands-on experience with modern data science / AI analytics tools such as Python (pandas/conda/matplotlib), R (tidyverse, plotly) or SAS and their related ecosystems
  • Proven success in building cross-functional partnerships and translating data into thoughtful, documented, risk-based decisions
  • Ability to effectively communicate complex data insights through compelling narratives to drive informed decision-making and foster a data-driven
  • Strong leadership, excellent communication, and stakeholder management skills
Job Responsibility
Job Responsibility
  • Embody Dompé’s commitment to ethics and integrity and values-based decision-making, and foster this mindset in clients, partners, and team members
  • Under the direction of the U.S. Compliance Officer, and will partner closely with the Legal, Information Communications Technology (ICT), Commercial Data Strategy and Operations, and Medical / R&D Teams
  • Design, implement, and manage a structured approach to analyze healthcare compliance-relevant data from various sources (e.g., investigations metrics, monitoring findings, transfers of value to healthcare professionals) to support a data-driven approach to U.S. healthcare compliance and risk management
  • Advise and create analytical requirements for dashboard creation, potential data requirements, and related business rules in order to bring necessary level of rigor
  • Ensure best practices for data reliability, ingestion, analysis, and output across various data streams
  • Develop strategy and support in enhancing key compliance systems, including but not limited to systems to review and approve key business activities (e.g., onboarding third parties, engaging healthcare professionals, reviewing external funding)
  • Assist in developing materials for Ethics & Compliance Committee meetings and other executive reporting, including external benchmarking, internal compliance metrics (e.g., dashboards), and compliance program vision
  • presents at such meetings where required
  • Evaluate and manage relationships with key systems, technology, and data vendors to maintain existing compliance systems and propose other cost-effective solutions
  • Identify and analyze regulatory landscape and external, industry trends regarding the use of technology and digital tools, including Artificial Intelligence (AI)
What we offer
What we offer
  • Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees
  • Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle
  • Competitive 401(K) matching
  • Fulltime
Read More
Arrow Right

Associate Director, Sterility Assurance

The Associate Director, Sterility Assurance, DP Manufacturing is a senior techni...
Location
Location
United States , Norwood
Salary
Salary:
142500.00 - 256500.00 USD / Year
modernatx.com Logo
Moderna
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
  • 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
  • Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
  • Strong expertise in risk assessment facilitation
  • Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership
  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations
Job Responsibility
Job Responsibility
  • Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations
  • Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution
  • Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control
  • Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy
  • Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions
  • Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making
  • Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices
  • Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements
  • Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections
  • Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics
What we offer
What we offer
  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities to help you plan for the future
  • Location-specific perks and extras
  • Eligible for an annual discretionary bonus, other incentive compensation, or equity award
  • Fulltime
Read More
Arrow Right